SBRT + Checkpoint Inhibitors for Cancer

Not currently recruiting at 11 trial locations
MV
YY
Overseen ByYoshiya Yamada, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Checkpoint inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining stereotactic body radiation therapy (SBRT) with checkpoint inhibitors can enhance the immune system's ability to fight cancer. Checkpoint inhibitors help the body's defenses attack cancer cells, but their effectiveness can diminish over time. The trial seeks to determine if SBRT can restore their efficacy, particularly for individuals with metastatic cancer. Those with certain types of metastatic cancer, such as melanoma or lung cancer, who have been on checkpoint inhibitor treatment for at least two months, may qualify. Participants should have up to five cancer spots with limited growth and be able to continue checkpoint inhibitor therapy after radiation. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must stop taking immunosuppressive medications like steroids at least 14 days before starting the trial. You can continue taking immune checkpoint inhibitors if you are already on them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that stereotactic body radiotherapy (SBRT) is generally safe and well-tolerated. Studies indicate that patients receiving SBRT for certain cancers have experienced good survival rates and manageable side effects. Specifically, one study found SBRT to be safe and effective for treating lung cancer, yielding positive results for patients.

Checkpoint inhibitors, already approved by the FDA for some cancer types, have passed safety checks for those uses. Although combining SBRT with checkpoint inhibitors is new in a formal trial, each treatment has demonstrated acceptable safety in previous studies.

Overall, both treatments have been well-received in other settings, suggesting they could be safe when used together. This will be confirmed in the trial.12345

Why are researchers excited about this trial's treatments?

Stereotactic Body Radiotherapy (SBRT) combined with checkpoint inhibitors is unique because it offers a targeted approach that can precisely hit cancer cells while minimizing damage to surrounding healthy tissue. Unlike conventional radiation therapy, which can affect larger areas, SBRT delivers high doses of radiation to very specific spots, potentially leading to fewer side effects and quicker recovery times. Additionally, checkpoint inhibitors work by unleashing the body's immune system to fight cancer more effectively. Researchers are excited about this combination because it could enhance the immune response against tumors, offering a powerful one-two punch that could outperform existing treatments like chemotherapy and standard radiation therapy.

What evidence suggests that the combination of SBRT and checkpoint inhibitors could be effective for cancer?

Studies have shown that stereotactic body radiation therapy (SBRT) effectively treats cancer. For example, two years after SBRT treatment, survival rates range from 80% to 90%. This type of radiation precisely targets tumors, often leading to better results. In this trial, researchers will combine SBRT with checkpoint inhibitors, which help the immune system fight cancer. This combination could enhance the effectiveness of these drugs. Although clinical trials have not formally tested this specific combination, it appears promising based on the individual effectiveness of each treatment.13467

Who Is on the Research Team?

YY

Yoshiya Yamada, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Adults with certain metastatic cancers (like melanoma, lung, bladder, renal, head/neck) who've been on approved checkpoint inhibitors for at least 2 months can join. They must have up to 5 progressing lesions and be able to continue immunotherapy post-radiation. Exclusions include active brain metastases, recent other treatments or severe allergies to monoclonal antibodies.

Inclusion Criteria

Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations
I can continue immune therapy after radiotherapy.
Your most recent scans show only a small amount of tumor growth, or up to 5 new or growing lesions. If you have more than 5 lesions, you can still join if the study doctors agree.
See 6 more

Exclusion Criteria

My brain cancer has been treated and stable for at least 8 weeks.
I do not have an active autoimmune disease, except for allowed conditions like vitiligo or type I diabetes.
I haven't taken steroids or immunosuppressants in the last 14 days, except for inhaled/topical ones or low-dose prednisone.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive stereotactic body radiation therapy (SBRT) to 1-3 lesions over 3 fractions

1-2 weeks
3 visits (in-person)

Treatment

Participants continue treatment with checkpoint inhibitors until progression or unacceptable toxicity

Up to 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Atezolizumab
  • Ipilimumab
  • Nivolumab
  • Pembrolizumab
  • Stereotactic Body Radiotherapy
Trial Overview The trial tests if high-precision radiation therapy (SBRT) can boost the effectiveness of FDA-approved checkpoint inhibitors like Ipilimumab, Nivolumab, Pembrolizumab or Atezolizumab in treating cancer that's started growing again.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Stereotactic Body RadiotherapyExperimental Treatment2 Interventions

Stereotactic Body Radiotherapy is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Stereotactic Body Radiation Therapy for:
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Approved in United States as Stereotactic Body Radiation Therapy for:
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Approved in Canada as Stereotactic Body Radiation Therapy for:
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Approved in Japan as Stereotactic Body Radiation Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Published Research Related to This Trial

The introduction of stereotactic ablative body radiotherapy (SABR) for stage I non-small-cell lung cancer (NSCLC) at a Scottish cancer center has led to improved median survival rates, increasing from 32.5 months before SABR was available to 48.8 months after its establishment.
SABR has not only improved survival outcomes but also increased the proportion of patients receiving radical therapy, particularly among younger and healthier patients, indicating its effectiveness as a treatment option.
Real-World Impact of SABR on Stage I Non-Small-Cell Lung Cancer Outcomes at a Scottish Cancer Centre.Stares, M., Lewis, G., Vallet, M., et al.[2023]
Stereotactic ablative radiotherapy (SABR) is the standard treatment for early-stage non-small-cell lung cancer that cannot be surgically removed, showing high rates of tumor control but facing challenges with regional and distant tumor failures.
Current research is exploring the use of immune checkpoint inhibitors as a systemic therapy option for patients treated with SABR, aiming to provide effective treatment with fewer side effects compared to traditional chemotherapy.
Inoperable Early-Stage Non-Small-Cell Lung Cancer: Stereotactic Ablative Radiotherapy and Rationale for Systemic Therapy.Daly, ME.[2022]
The addition of stereotactic body radiation therapy (SBRT) to checkpoint inhibitor (CPI) immunotherapy in 35 patients with metastatic non-small cell lung cancer was found to be safe, with no severe radiation-induced toxicities (grade 3 to 5) reported.
The combination treatment resulted in a best systemic objective response rate of 53%, indicating a promising efficacy that supports the need for further randomized trials to explore this approach.
A Prospective Trial Evaluating the Safety and Systemic Response From the Concurrent Use of Radiation Therapy with Checkpoint Inhibitor Immunotherapy in Metastatic Non-Small Cell Lung Cancer.Mattes, MD., Eubank, TD., Almubarak, M., et al.[2022]

Citations

A systematic review of outcomes following stereotactic ...Although not statistically significant, the 3- and 5- year survival rates for the patients who received SABR plus adjuvant chemotherapy were 80.5% and 46%, ...
Success Rate and Survival After Stereotactic RadiotherapyThis difference in delivery leads to substantially better outcomes, with two-year success rates for SBRT ranging from 80% to 90%, comparable to ...
Clinical outcomes and efficacy of stereotactic body radiation ...The objective of this study is to report disease outcomes and toxicity with the use of stereotactic body radiation therapy (SBRT) in the treatment of ...
Safety and Efficacy Results From iSABR, a Phase 1 Study ...Stereotactic ablative radiotherapy (SABR) is increasingly used for the treatment of early-stage non-small cell lung cancer (ES-NSCLC) and for pulmonary ...
Historical Versus Modern Data of Stereotactic Ablative ...The results support the utilization of SABR for these patients (with a 90-day toxicity rate of 3.8% and a 90-day all-cause mortality of 1.7%), but more ...
Safety and Survival Rates Associated With Ablative ...The findings of this study suggest that stereotactic ablative radiotherapy is generally safe and well tolerated in the oligometastatic setting.
Comparison of outcome after stereotactic ablative ...In conclusion, our results show that SABR is safe and effective treatment for stage I metachronous lung cancer, with outcomes not ...
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